Negative Pressure Wound Therapy: Are All Systems Alike?
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- 5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
研究概览
简要总结
Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).
详细描述
This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adults requiring negative pressure dressings.
排除标准
- •Mentally obtunded
- •Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
- •Presence of Manufacturer's contraindications
- •Malignancy in wound
- •Untreated osteomyelitis
- •Unexplored fistula
- •Necrotic tissue
- •Exposed blood vessels or organs
- •Untreated malnutrition.
结局指标
主要结局
5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling
时间窗: first dressing change; typically within 48 hours
differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler
次要结局
- Ease of Performing Dressing Change(during hospital stay; generally 6 days)
- Ease of Providing Nursing Care(during hospital stay; generally 6 days)
- Cost of Wound Care(during hospital stay; generally 6 days)
- Nursing Time(hospital stay; generally 6 days)
- Patient Reported Pain(at first dressing change; generally 48 hours)